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Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress (PST on stress)

Primary Purpose

Stress, Psychological, Behavior, Occupational Stress

Status
Unknown status
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Problem Solving Therapy offered through a web platform
Conventional web platform
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress, Psychological

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Workers between 25 to 50 years of age poor conditions to be able to develop a therapy through a web platform.
  • Workers with self-perceived stress scale and work stress with scores considered as stress.
  • Working time ≥ one year.
  • With signed informed consent.
  • Workers with access to a computer connected to the internet during their working hours.
  • Workers with ranges on the stress scale up to 2 standard deviations above the average.

Exclusion Criteria:

  • Workers are taking anti-anxiety drugs and antidepressants, who scheduled their vacations during the follow-up period.
  • People who for any physical or mental disability cannot use the web platform
  • Workers with ranges on the stress scale for above three standard deviations above the average.

Sites / Locations

  • Universidad Peruana Cayetano HerediaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Conventional web platform

Problem Solving Therapy offered through a web platform

Arm Description

Participants asked to review the web platform for 4 weeks.

4 sessions with cognitive behavioral therapy, offered through a web platform. Each session will be offered per week.

Outcomes

Primary Outcome Measures

Change in Self-perceived stress scale score
Perceived Stress Scale (PSS) It's formed by 14 items that measure the degree to which, during the last month, people have felt upset or worried or, on the contrary, have felt confident in their ability to control their personal problems. Scale scores between 0-56, with higher scores indicating greater stress perceived. Use a five-way Likert response format with a range of 0 "Never") to 4 ("Very often"). The cut point for determinate stress is 20.9 points (14 + 1 SD (6.9)) for hispanics. [ L. Harris Pol]

Secondary Outcome Measures

Change in Occupational stress scale
Change in Occupational stress scale. This instrument has as author ILO-WHO. The questions are 25 with 7 alternatives such as answers ranging from the score from 1 to 7, of as follows. [1= if the condition 'Never' is a source of stress. 2 = if the condition 'Rarely' is a source of stress. 3 = if the condition 'Occasionally' is a source of stress 4 = if the condition 'Sometimes' is a source of stress. 5 = if the condition 'Frequently' is a source of stress 6 = if the condition "specifically" is a source of stress. 7 = if the "Always" condition is a source of stress.] The scale determinate the cut point for stress in 120 for Peruvian population. (Suaréz A. 2013)

Full Information

First Posted
July 8, 2019
Last Updated
June 5, 2020
Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04016883
Brief Title
Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress
Acronym
PST on stress
Official Title
Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Perceived Stress by Administrative Workers: A Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Peruana Cayetano Heredia
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Work-related stress is a problem due to its repercussions on workers' health and productivity, which is why workplace interventions are required to reduce stress levels through coping techniques. One of the interventions in mental health to reduce levels of work stress are those based on the Internet and mobile applications, with proven effectiveness. Among the interventions are cognitive-behavioral therapies and within these the Problem Solving Therapy (PST). Therefore, there is a need to study the effect of Problem Solving Therapy offered through a web platform on the levels of self-perceived stress. However, there have been no studies on mental health interventions such as the TSP for the reduction of stress levels in office workers. For this reason, the objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels. Two scales will measure the levels of stress; one for self-perceived stress and another for work-related stress. Workers who have a high score on both scales will be enrolled. The establishments assigned to the intervention will receive the TSP distributed in 4 sessions. The establishments in the control group would have access to a web page with information on stress management. Immediately after having finished the last session, self-perceived stress levels will be evaluated. One month later a new measurement will be made to evaluate the persistence of the effect.
Detailed Description
The objective of the study is to determine, through a randomized cluster trial, the effectiveness of problem-solving therapy offered through a web platform on self-perceived stress levels. Overall objective Evaluate the effect of Problem Solving Therapy offered through a web platform, on the self-perceived stress level of administrative workers. Specific objectives Develop and validate a web platform with problem-solving therapy. Determine the cut-off point of self-perceived stress measurement scales. Evaluate the factors associated with stress in office workers. Compare the levels of Perceived stress scale (PSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST). Compare the effect of a conventional platform versus the Problem Solving Therapy offered through a web platform on self-perceived stress levels. Compare the levels of occupational stress (OSS) before and after the use of a web platform with educational material in Problem Solving Therapy (PST). Compare the effect of Problem Solving Therapy offered through a web platform versus a conventional web platform on work stress levels (WSS). Evaluate the correlation between the perceived stress scale and the occupational stress scale (OSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Behavior, Occupational Stress, Mental Health Wellness 1

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a randomized controlled trial of parallel type (2 arms, with a ratio of 1: 1, and with a block size of 5), which consists of the following phases where necessary changes in the methods are described after to start the trial:
Masking
Investigator
Masking Description
double-blind masking
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional web platform
Arm Type
Sham Comparator
Arm Description
Participants asked to review the web platform for 4 weeks.
Arm Title
Problem Solving Therapy offered through a web platform
Arm Type
Experimental
Arm Description
4 sessions with cognitive behavioral therapy, offered through a web platform. Each session will be offered per week.
Intervention Type
Other
Intervention Name(s)
Problem Solving Therapy offered through a web platform
Intervention Description
Problem Solving Therapy offered through a web platform. There will be four sessions, during the first four weeks of treatment, and subsequent sessions are dedicated to refining problem-solving skills. Participants set treatment goals; different ways to reach goals are discussed and evaluated; action plans are created, and its effectiveness is evaluated to achieve the objectives. Participants are expected to implement plans and apply the problem-solving model to additional problems between sessions. In the last two sessions, participants create a relapse prevention plan using the problem-solving therapy model.
Intervention Type
Other
Intervention Name(s)
Conventional web platform
Intervention Description
The conventional web platform, which will contain the general content on stress coping techniques.
Primary Outcome Measure Information:
Title
Change in Self-perceived stress scale score
Description
Perceived Stress Scale (PSS) It's formed by 14 items that measure the degree to which, during the last month, people have felt upset or worried or, on the contrary, have felt confident in their ability to control their personal problems. Scale scores between 0-56, with higher scores indicating greater stress perceived. Use a five-way Likert response format with a range of 0 "Never") to 4 ("Very often"). The cut point for determinate stress is 20.9 points (14 + 1 SD (6.9)) for hispanics. [ L. Harris Pol]
Time Frame
0 and 5 weeks
Secondary Outcome Measure Information:
Title
Change in Occupational stress scale
Description
Change in Occupational stress scale. This instrument has as author ILO-WHO. The questions are 25 with 7 alternatives such as answers ranging from the score from 1 to 7, of as follows. [1= if the condition 'Never' is a source of stress. 2 = if the condition 'Rarely' is a source of stress. 3 = if the condition 'Occasionally' is a source of stress 4 = if the condition 'Sometimes' is a source of stress. 5 = if the condition 'Frequently' is a source of stress 6 = if the condition "specifically" is a source of stress. 7 = if the "Always" condition is a source of stress.] The scale determinate the cut point for stress in 120 for Peruvian population. (Suaréz A. 2013)
Time Frame
0 and 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Workers between 25 to 50 years of age poor conditions to be able to develop a therapy through a web platform. Workers with self-perceived stress scale and work stress with scores considered as stress. Working time ≥ one year. With signed informed consent. Workers with access to a computer connected to the internet during their working hours. Workers with ranges on the stress scale up to 2 standard deviations above the average. Exclusion Criteria: Workers are taking anti-anxiety drugs and antidepressants, who scheduled their vacations during the follow-up period. People who for any physical or mental disability cannot use the web platform Workers with ranges on the stress scale for above three standard deviations above the average.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Carcamo, MD
Phone
997350773
Email
cesar.carcamo@upch.pe
Facility Information:
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
ZIP/Postal Code
07056
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Arapa, Research
Phone
+51944203312
Email
katherine.arapa.a@upch.pe

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared
Citations:
PubMed Identifier
23855376
Citation
Heber E, Ebert DD, Lehr D, Nobis S, Berking M, Riper H. Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial. BMC Public Health. 2013 Jul 15;13:655. doi: 10.1186/1471-2458-13-655.
Results Reference
background
PubMed Identifier
26818683
Citation
Heber E, Lehr D, Ebert DD, Berking M, Riper H. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial. J Med Internet Res. 2016 Jan 27;18(1):e21. doi: 10.2196/jmir.5112.
Results Reference
result

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Effect of Problem-solving Therapy Offered Through a Web Platform on Levels of Stress

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